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Code · BILL · 113th Congress · H.R. 5835 (Introduced in House) — To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act with respect to making progress t... · Sec. 2

Sec. 2. Findings

380 words·~2 min read·/bill/113/hr/5835/ih/section-2

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The Congress finds as follows: Each year approximately 9,000,000 people become ill with active tuberculosis (TB), an airborne infectious disease, and it is estimated that 1,500,000 of those people die, making TB the second leading global infectious disease killer. There is a global underinvestment in quality TB control, and in the research and development of new drugs, diagnostics and a vaccine, as well as in the relationship between TB and HIV/AIDS. The increasing occurrence of multi-drug resistant ( MDR ) TB, including extensively drug resistant ( XDR ) TB which is resistant to at least two of the recommended first-line drugs and the recommended second-line medications, is a serious and emerging global health problem.
Cases of TB are reported annually in every State within the United States, with a total of 9,582 cases of active TB reported in the United States in 2013. In addition to those with active TB, an estimated 8,000,000 to 10,000,000 people in the United States are infected with the TB bacteria. Drug-resistant TB poses a particular challenge to domestic TB control due to the high costs of treatment and intensive health care resources required. Treatment costs for MDR TB range from $100,000 to $300,000, which can cause a serious strain on State public health budgets.
In 2013, the United States experienced serious shortages of first- and second-line TB drugs and biologics, including isoniazid, the first-line TB drug, and tubersol, the biologic used in TB skin tests. New tools are urgently needed to more effectively prevent, diagnose, and treat TB. Within the last 40 years, only one new TB drug has been developed and approved in the United States, and the treatment regimen for MDR TB remains excessively lengthy, toxic, and difficult for patients to tolerate.
The existing vaccine, which is not used in the United States, confers no protection to adolescents and adults, protecting only against pulmonary TB in infants and children. The expertise in identifying, treating, and preventing TB is within the Centers for Disease Control and Prevention and the United States public health system. The identification and preventive treatment of the millions of people in the United States with TB infection, representing the reservoir of future active TB cases, is a key component of the strategy to eliminate TB in the United States.
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